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Pharmacoepidemiology and Drug Safety

John G Connolly, Sebastian Schneeweiss, Robert J Glynn, Joshua J Gagne
PURPOSE: Implementing a cohort study in longitudinal healthcare databases requires looking back over some covariate assessment period (CAP) preceding cohort entry to measure confounders. We used simulations to compare fixed-duration versus all-available CAPs for confounder adjustment in the presence of differences in available baseline time between exposure groups. METHODS: We simulated cohorts of 10 000 patients with binary variables for a single confounder, exposure, and outcome...
February 20, 2019: Pharmacoepidemiology and Drug Safety
Si Si, Richard Ofori-Asenso, Tom Briffa, Frank M Sanfilippo, Jenni Ilomaki, XiWen Qin, Mark Tacey, Christopher M Reid, Danny Liew
PURPOSE: Poor adherence and persistence to blood pressure lowering (BPL) agents leads to increased risk of morbidity and mortality. The aim of this study was to investigate the long-term adherence, persistence, and re-initiation of BPL agents among older Australians (aged ≥65 years). METHODS: We utilised the Pharmaceutical Benefits Scheme data covering a 10% random sample of Australians. We identified 31 088 older Australians (mean age, 75.4 years; 56% females) with newly initiated BPL therapy from 2008 to 2016...
February 19, 2019: Pharmacoepidemiology and Drug Safety
Francesco Cottone, Amelie Anota, Franck Bonnetain, Gary S Collins, Fabio Efficace
PURPOSE: The aim of this study was to investigate the potential added value of combining propensity score (PS) methods with multivariable linear regression (MLR) in estimating the average treatment effect on the treated (ATT) in nonrandomized studies with health-related quality of life (HRQoL) outcomes. METHODS: We first used simulations to compare the performances of different PS-based methods, either alone or in combination with further MLR adjustment, in estimating ATT...
February 19, 2019: Pharmacoepidemiology and Drug Safety
Anders H Riis, Rune Erichsen, Eva B Ostenfeld, Carsten S Højskov, Ole Thorlacius-Ussing, Mogens Tornby Stender, Timothy L Lash, Holger Jon Møller
PURPOSE: To validate prescription registry data as a measurement of adherence to statins through a direct method using assays for selected statins in serial blood samples collected from two prospective cohorts of Danish colorectal cancer patients. METHODS: We linked information on statin prescriptions from the Aarhus University Prescription Database with the cancer cohorts from Aalborg University Hospital. For statin-prescribed patients, we calculated a prescription window covering the anticipated duration of the prescription...
February 19, 2019: Pharmacoepidemiology and Drug Safety
Igor Karp, Atul Sivaswamy, Christopher Booth
PURPOSE: Incretin-based medications are a novel class of agents for the treatment of type-2 diabetes mellitus (DM2). The safety profile of these medications is not firmly established, and concerns have been raised about their potential carcinogenicity. The objective of our study was to produce new evidence on the effect of incretin-based medications on cancer risk in patients with DM2. METHODS: We conducted a "retrospective cohort" study with data from the Clinical Practice Research Datalink and the Hospital Episodes Statistics in the UK...
February 18, 2019: Pharmacoepidemiology and Drug Safety
Kristina Star, Lovisa Sandberg, Tomas Bergvall, Imti Choonara, Pia Caduff-Janosa, I Ralph Edwards
PURPOSE: The purpose of this study is to uncover previously unrecognised risks of medicines in paediatric pharmacovigilance reports and thereby advance a safer use of medicines in paediatrics. METHODS: Individual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, in September 2014. The reports were grouped according to the following age spans: 0 to 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years...
February 15, 2019: Pharmacoepidemiology and Drug Safety
Timothy S Anderson, Edison Xu, Evans Whitaker, Michael A Steinman
PURPOSE: Pharmacy dispensing databases are often used to identify patients' medications at a particular time point, for example to measure prescribing quality or the impact of medication use on clinical outcomes. We performed a systematic review of studies that examined methods to assess medications in use at a specific point in time. METHODS: Comprehensive literature search to identify studies that compared active medications identified using pharmacy databases to medications identified using nonautomated data sources...
February 13, 2019: Pharmacoepidemiology and Drug Safety
Helene G van der Meer, Katja Taxis, Martina Teichert, Fabiënne Griens, Lisa G Pont, Hans Wouters
PURPOSE: To identify the proportion of older adults with a high anticholinergic/sedative load and to identify patient subgroups based on type of central nervous system (CNS)-active medication used. METHODS: A cross-sectional study of a nationwide sample of patients with anticholinergic/sedative medications dispensed by 1779 community pharmacies in the Netherlands (90% of all community pharmacies) in November 2016 was conducted. Patients aged older than 65 years with a high anticholinergic/sedative load defined as having a drug burden index (DBI) greater than 1 were included...
February 12, 2019: Pharmacoepidemiology and Drug Safety
Noelle M Cocoros, Anita Wagner, Kevin Haynes, Andrew B Petrone, Elnara Fazio-Eynullayeva, Yulan Ding, Rima Izem, Joo-Yeon Lee, Jacqueline M Major, Michael Nguyen, Jing Ju
PURPOSE: Develop a flexible analytic tool for the Food and Drug Administration's (FDA's) Sentinel System to assess adherence to safe use recommendations with two capabilities: characterize adherence to patient monitoring recommendations for a drug, and characterize concomitant medication use before, during, and/or after drug therapy. METHODS: We applied the tool in the Sentinel Distributed Database to assess adherence to the labeled recommendation that patients treated with dronedarone undergo electrocardiogram (ECG) testing no less often than every 3 months...
February 12, 2019: Pharmacoepidemiology and Drug Safety
Oddbjørn Hove, Eva Biringer, Odd E Havik, Jörg Assmus, Kirsten J Braatveit, Silje Elisabeth Hasmo Holm, Monica Hermann
PURPOSE: Individuals with intellectual disabilities (IDs) have more health problems, a poorer general health, and a shorter life expectancy than individuals in general. High rates of drug use in IDs have been reported. Despite the increasing interest in health problems in individuals with IDs, little is known about their drug use. METHOD: Drug use in a community sample of adults with IDs (N = 593) was compared with dispensed drugs in a time-, age-, and region-matched comparison group of adults in Western Norway (N = 289 325)...
February 12, 2019: Pharmacoepidemiology and Drug Safety
Keval Dabba, Matthew Elswood, Ahmed Ameer, David Gerrett, Ian Maidment
PURPOSE: To review and analyse medication errors related to clozapine, an atypical antipsychotic, that were reported to the National Reporting and Learning System (NRLS). METHODS: Following extraction of one year of clozapine related errors from the NRLS, a qualitative analysis (thematic analysis and re-classification) and quantitative analysis was performed. An incident was considered a clozapine error if there was a failure in its medication process (i.e. an error in the prescribing, dispensing, preparing, administering, monitoring or advising of clozapine)...
February 10, 2019: Pharmacoepidemiology and Drug Safety
Courtney Baker, James A Feinstein, Xuan Ma, Shari Bolen, Neal V Dawson, Negar Golchin, Alexis Horace, Lawrence C Kleinman, Sharon B Meropol, Elia M Pestana Knight, Almut G Winterstein, Paul M Bakaki
PURPOSE: To examine the range of prevalence of pediatric polypharmacy in literature through a scoping review, focusing on factors that contribute to its heterogeneity in order to improve the design and reporting of quality improvement, pharmacovigilance, and research studies. METHODS: We searched Ovid Medline, PubMed, EMBASE, CINAHL, Ovid PsycINFO, Cochrane CENTRAL, and Web of Science Core Collection databases for studies with concepts of children and polypharmacy, along with a hand search of the bibliographies of six reviews and 30 included studies...
February 6, 2019: Pharmacoepidemiology and Drug Safety
Chen-Yu Wang, Shau-Huai Fu, Rong-Sen Yang, Fei-Yuan Hsiao
PURPOSE: The objective of this study was to investigate the association between the administration of dipeptidyl peptidase-4 (DPP-4) inhibitors (cumulative duration, timing, and individual substance) and the risk of arthralgia by using a nationwide database with two methodological approaches including cohort and nested case-control study designs. METHODS: Using Taiwan's National Health Insurance Research Database, we identified patients who were newly prescribed with DPP-4 inhibitors, thiazolidinediones (TZDs), or acarbose between 1 March 2009 and 31 December 2012...
February 6, 2019: Pharmacoepidemiology and Drug Safety
Ramin Mojtabai, Masoumeh Amin-Esmaeili, Eleeka Nejat, Mark Olfson
PURPOSE: To assess the prevalence and correlates of self-reported misuse of prescribed-opioid medications in the US general population. METHOD: In 31 068 adult participants of the National Survey on Drug Use and Health (NSDUH) 2015 and 2016 who reported using opioids in the past year, we assessed the prevalence and correlates of self-reported misuse of prescribed opioids, defined as using a larger dose, more frequently, or longer than prescribed. Multivariable logistic-regression models and the machine-learning method of boosted regression were used to identify the correlates of misuse...
February 5, 2019: Pharmacoepidemiology and Drug Safety
Nancy A Brandenburg, Syd Phillips, Karen E Wells, Kimberley J Woodcroft, Kandace L Amend, Cheryl Enger, Susan A Oliveria
PURPOSE: Large numbers of multiple myeloma patients can be studied in real-world clinical settings using administrative databases. The validity of these studies is contingent upon accurate case identification. Our objective was to develop and evaluate algorithms to use with administrative data to identify multiple myeloma cases. METHODS: Patients aged ≥18 years with ≥1 International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for multiple myeloma (203...
February 4, 2019: Pharmacoepidemiology and Drug Safety
Nabarun Dasgupta, John Schwarz, Sean Hennessy, Askhan Ertefaie, Richard C Dart
PURPOSE: One response to the opioid crisis in the United States has been the development of opioid analgesics with properties intended to reduce non-oral use. Previous evaluations of abuse in the community have relied on population averaged interrupted time series Poisson models with utilization offsets. However, competing interventions and secular trends complicate interpretation of time-series analyses. An alternative research design, trend-in-trend, accounts for heterogeneity in per capita opioid dispensing and unmeasured time-varying confounding, which provides a causal evaluation, provided that underlying assumptions are met...
February 3, 2019: Pharmacoepidemiology and Drug Safety
Bernhardt Sachs, Diana Dubrall, Wilma Fischer-Barth, Matthias Schmid, Julia Stingl
PURPOSE: The main objective of this study was to analyze validated cases of drug-induced anaphylactic reactions in children with regard to incriminated drugs, clinical characteristics, and associated factors. A further objective was to compare differences in incriminated drugs and characteristics between validated cases and a reference excluding anaphylactic reaction cases (basic dataset). METHODS: Spontaneous reports of anaphylactic reactions in children (0-17 years) registered between January 2000 to December 2016 were extracted from the adverse drug reaction database of the German Federal Institute for Drugs and Medical Devices...
January 31, 2019: Pharmacoepidemiology and Drug Safety
Reimar Wernich Thomsen, Szimonetta Komjáthiné Szépligeti, Fei Xue, Lars Pedersen, Henrik Toft Sørensen, Vera Ehrenstein
PURPOSE: Population-based data are sparse on utilization of prophylactic versus acute therapies for newly diagnosed migraine. We examined initial migraine treatment patterns and associated patient characteristics in Denmark. METHODS: We used population-based health databases to assemble a nationwide cohort of adult migraine patients in 2005 to 2013. Migraine was defined as a first hospital diagnosis of migraine or a second redeemed outpatient prescription for triptans, ergots, pizotifen, or flunarizine...
January 31, 2019: Pharmacoepidemiology and Drug Safety
Kevin Haynes
No abstract text is available yet for this article.
January 31, 2019: Pharmacoepidemiology and Drug Safety
Alys Havard, Peter Straka, Grant Sara, Sanja Lujic, Duong T Tran, Louisa R Jorm
PURPOSE: Records of antidepressant dispensings are often used as a surrogate measure of depression. However, as antidepressants are frequently prescribed for indications other than depression, this is likely to result in misclassification. This study aimed to develop a predictive algorithm that identifies patients using antidepressants for the treatment of depression. METHODS: Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) claims data were linked to follow-up questionnaires (completed in 2012-2013) for participants of the 45 and Up Study-a cohort study of residents of New South Wales, Australia, aged 45 years and older...
January 25, 2019: Pharmacoepidemiology and Drug Safety
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